The client decided to conduct this study outside of the US so they would not need to submit the study to the IND.
Our international field, data accession, and consultant team selected and managed 1 site each in Ecuador, New Zealand, South Africa and Sweden. The team enrolled the required number of patients in 16 weeks. The data were transmitted in real time to Saratoga Springs, NY, where the database was closed within two weeks. This information was provided to our statistical group, which completed the analysis and final clinical study report ahead of schedule.
Criterium offered an experienced team in the Southern Hemisphere to get approval by the regulatory authorities of this placebo-controlled respiratory infection study, to extend the recruitment to 10 months of the year and to enroll at a higher rate per site than the previous seasons’ site enrollment rates.
Criterium’s team averaged more patients per site than
the Northern Hemisphere at a high compliance rate for the target
Criterium experienced teams in South Africa,
Russia and Ukraine met with the agencies and the Ethics committees
to expedite approval of this protocol during the first of
each of their regulatory cycles.
The client was in danger of missing its deadline because of a protracted RFP process in choosing a CRO.
Our international field, data accession, and consultant team solicited sites in South Africa. The team enrolled and evaluated the required number of patients in 12 weeks. The data were transmitted in real time to Saratoga Springs, NY, where the database was closed within two weeks. This information was provided to our West Coast consulting group, which completed the final clinical study report ahead of schedule.
Criterium offered an integrated technology-enhanced solution that allowed the sites to register patients and allowed the patients to record their event data directly into our remote systems.
Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.
Because the estimated patient compliance rate was critical for the statistical analysis, Criterium daily monitored the patient diaries.
Through StudyControl™, Criterium designed reports to evaluate the compliance of each patient during the study. When patient compliance was less than predicted, Criterium informed the client immediately. This critical intervention enabled the sponsor to enroll additional patients into the study. Additionally, daily management of the site by Criterium’s knowledgeable staff members helped ensure that patient compliance among the additional study participants was at the highest level, thereby meeting the study’s control requirements.